Heart failure (HF) is a major health problem in India with a postadmission mortality of 20%–30%. Medication adherence ranges from 25% to 50%, and the tolerance of guideline-based medication is low for Indian patients. We took out guidelines on HF in 2015, and this update covers the changes which have occurred in HF management in the past 2 years. As a number of new drugs such as angiotensin receptor-neprilysin inhibitor and ivabradine have been approved for use in India, devices such as implantable cardioverter-defibrillators and cardiac resynchronization therapy are becoming more accessible and more left ventricular assist devices and transplants are being done in India, there is need for clear guidelines for the use of each which are practical for India.

Heart failure (HF) is a major health problem in India with a postadmission mortality of 20%–30%. Medication adherence ranges from 25% to 50%, and the tolerance of guideline-based medication is low for Indian patients. Devices such as implantable cardioverter-defibrillators (ICD) and cardiac resynchronization therapy (CRT) devices and left ventricular assist devices (LVAD) are available but not within the reach of all. Heart transplant, the final treatment for HF, is gradually picking up in numbers all over the country. Having limited resources to treat such a major problem, it is necessary to have India-specific guidelines for HF. We took out guidelines on HF in 2015, and this update covers the changes which have occurred in HF management in the past 2 years. As a number of new drugs have been approved for use in India, devices such as ICDs and CRTs are becoming more accessible and more LVADs and transplants are being done in India, there is need for clear guidelines for the use of each which are practical for India.

Acute Heart Failure

Acute HF, which is the rapid onset or worsening of HF, has a very high mortality in India and is commonly due to systolic dysfunction due to ischemic heart disease (IHD) or cardiomyopathies (commonly dilated cardiomyopathy), uncontrolled hypertension or other causes, and valvular heart disease commonly rheumatic.[1]

The treatment components are discussed below.

Initial stabilization

Airway assessment and checking oxygen saturation

Supplemental oxygen is needed if saturation dips (SpO2 <90%). Oxygen should not be used routinely as it causes vasoconstriction and falls in cardiac output. If there is associated respiratory distress, with respiratory acidosis, then a trial of noninvasive ventilation can be tried. If this fails (PaO2 <60%, PCo2 >50%, pH <7.35), then mechanical ventilation with positive end-expiratory pressure is used.

Assessing vitals

Intravenous (IV) access

Seated posture

Diuretic therapy

Diuretics are the mainstay with furosemide (20–40 mg) or torsemide (10–20 mg). This can be repeated at 2 hourly intervals. The dose can go up to 200 mg of furosemide

Patients need greater (2.5 times) than their usual maintenance doses at admission. These patients often need a bolus of 80 mg furosemide along with an infusion of 5–30 mg/h of furosemide along with metolazone at 5 mg once or twice daily. Continuous infusions will work only if bolus injections have worked. While on IV diuretics, daily sodium and potassium monitoring should be done. The target is to ensure a urine output of greater than 3 L in the first few days.

Vasodilators

Nitrates are commonly used, specifically IV nitroglycerine, and is easy to titrate from an initial dose of 5–10 mcg/min with increments every 5 min up to 200 mcg/min. It should not be used with right ventricular infarction or aortic stenosis. IV nitroprusside is more potent and requires intra-arterial pressure monitoring during its use and may be required with acute mitral regurgitation or acute ventricular septal defect or an acute aortic regurgitation.

Finding and treating the cause (start soon after the initial stabilization)

Acute HF is due to either IHD (myocardial infarction with massive myocardial necrosis, or a ventricular septal rupture or acute mitral regurgitation), myocarditis, valvular heart disease like acute mitral regurgitation or acute aortic regurgitation or mitral stenosis, decompensation of previous chronic HF or accelerated hypertension or an arrhythmia or a pulmonary embolism. Other causes are less common. Each of these causes has different pathways of management which should be followed along with the management of HF.

Treating the precipitating cause: Quite often, there is a precipitating cause such as anemia, infection, arrhythmia, endocrine disorders which can if corrected, help in stabilizing HF.

Venous thromboembolism prophylaxis: This is recommended in patients with heparin or a compression device

Vasopressin receptor antagonists: This can be considered in patients with persistent hyponatremia (sodium <120 meq/L) in spite of guideline-based therapy. Tolvaptan is the drug available easily

Use of inotropes: If the patient is in shock with a systolic blood pressure below 85 mmHg with evidence of shock with cool extremities, narrow pulse pressure, low urine output, or confusion, then an inotrope (dobutamine or milrinone) is indicated. If shock persists, then a vasopressor (dopamine or norepinephrine preferably) should also be added. In refractory patients, mechanical support with intra-aortic balloon pump and extracorporeal membrane oxygenator (ECMO) should be considered.

Role of mechanical circulatory support

Patients who are refractory to the above care should be considered for more definitive care like a ventricular assist device or a heart transplant. To stabilize such patients, they will need a temporary mechanical circulatory support like an intra-aortic balloon pump or ECMO support. In some centers, a temporary ventricular assist device called a CentriMag (like an ECMO without oxygenation) can also be inserted.

Long-term planning

Once the patients stabilize, then the patient should be mobilized and discharge planning should start.

Medications

Angiotensin-converting enzyme (ACE) inhibition or angiotensin receptor blockers (ARBs) should be started in low doses in all patients and increased in very slow increments every 2nd day. The dose can be split into two halves to reduce the incidence of hypotension. These can be initiated even with a low blood pressure as long as the patient is mobile and not symptomatic with hypotension. If there is renal dysfunction, then a combination of hydralazine and nitrates can be started in low doses till the renal function improves.

Beta blockers are to be initiated only when the patient is:

Mobile

Off IV diuretics and inotropes

Having no systemic or pulmonary congestion

Mobilized.

Start a very low dose of any approved beta blocker (carvedilol, metoprolol succinate or bisoprolol) and build up the dose very gradually

Diuretics: It should be switched to oral diuretics at a slightly higher dose in case of furosemide and similar doses with torsemide. A mineralocorticoid receptor antagonist should be added

Influenza and pneumococcal vaccines should be given

Control of other co-morbidities: Diabetics, thyroid abnormalities, and other problems should be controlled during the admission.

Discharge planning

Patient education: Patient needs to be taught about their disease, their medications, need to control their salt and water intake. They should be taught how to respond to shortness of breath by restricting fluid and increasing their diuretic pills

Doctor visit at day 7: Data show clearly that majority of events after an HF admission occurs within a month, and therefore, it is very important to schedule the visits of the patients to see the doctors. The first visit after discharge should always be scheduled within 7 days of discharge

A Disease Management Program/HF Clinic/HF Nurses: There is evidence that a disease management program can improve the medication adherence and quality of life of patients with HF, and therefore, it is useful to create a simple disease management program where the patients are able to contact a nurse for their daily problems and who also contacts them on a regular basis to help uptitrate the medication. This helps with medication adherence and also reduces hospital readmissions.

Chronic Heart Failure

This is the second set of guidelines being taken out on HF. The first set of guidelines was taken out in 2015. Both prevention and therapy are important. These guidelines include data which have come out in the past 2 years.

The Trivandrum HF registry (THFR) was funded by the ICMR.[23] The registry enrolled 1205 consecutive admissions (834 men, 69%) using the ESC 2012 criteria for enrollment. The mean age was 61.2 (13.7) years. The most common etiology of HF was IHD (72%).

Guideline-based therapy was found to improve outcomes but dismally suboptimal (25%).

Chaturvedi and Seth et al. have attempted to estimate the burden of HF in India.[22] Adults of six villages in Northern India were screened, and cases of dyspnea were identified by trained health workers. Of 10,163 cases screened, chronic breathlessness was present in 128 (1.3%). The prevalence of HF in this rural community was estimated to be 1.2/1000.

Regarding etiology of HF, there was disconnect between hospital data and community data in the current study. In the community study, two-thirds of the patients had HFpEF, and all of them had uncontrolled hypertension (HTN). In the in-hospital group, RHD (52%) was the most common cause followed by IHD (17%). RHD (37.1%) was the most common etiology followed by CAD (33.4%) in another tertiary hospital cohort. The authors did an estimation of the prevalence of HF in India based on whatever minimal data were available and also did projections based on data from the West. They estimated that the prevalence of HF to be about 1% (8–10 million) individuals and the mortality attributable to HF is about 0.1–0.16 million individuals per year.

The AFAR STUDY: The study group was comprised of 90 patients.[24] The mean age was 53.5 ± 17.7 years, and the majority of patients were men (63.0%) with LV systolic dysfunction. The leading causes of HF in this cohort were ischemic cardiomyopathy (53.9%), idiopathic cardiomyopathy (18.5%), and rheumatic heart disease (10.8%). In-hospital mortality was 30.8%. The majority of in-hospital deaths were due to progressive HF (92%), and the rest were due to intractable arrhythmias (6%) or renal failure. Cumulative 1-month, 3-month, and 6-month mortality rates of discharged patients were 15.8%, 26.3%, and 26.3%, respectively. This suggested that the maximum events were occurring either within the hospital or within 3 months following discharge. Combined postdischarge major adverse event rates (death or re-hospitalization) were 27.3% and 38.1% at 1 month and 6 months, respectively.

Management

This includes appropriate use of vasodilators (ACE inhibitors [ACEIs], ARBs or a combination of hydralazine and nitrates) along with a heart rate reduction with beta blockers with or without ivabradine. Diuretics with mineralocorticoid receptor antagonists are to be used appropriately. Digoxin can have a role in refractory HF and patients with atrial fibrillation [Figure 1].

ARBs can be used and include losartan (25–50 mg QD −>50–150 mg QD) and valsartan (20–40 mg BD −> to 160 mg BD).

ARNI (sacubitril/valsartan) is started at a dose of 24/26 mg BD, i.e., a 50 mg tablet twice a day as long as the blood pressure is above 100 mmHg systolic. ACEIs are stopped for 2 days before starting ARNI and ARBs are stopped, and ARNI started the next day. ARNI is started at 50 mg twice daily (if not on ACEI or on very low doses) and 100 mg twice daily if on higher doses of ACEI. In Indian patients, due to lower body weight, starting at a lower dose of half a 50 mg tablet twice a day, allows lesser drug withdrawal withdrawal and more easier titration, especially if the starting blood pressure is low or the previous dose of ACEI or ARB was low.

Isosorbide dinitrate and hydralazine: Combination should be used in patients where ACEI or ARB cannot be used due to renal problems. Fixed dose combination (20 mg isosorbide dinitrate/37.5 mg hydralazine) gives one or two tablets thrice daily.

Ivabradine: In India, the doses to which beta blockers can be titrated are very low (carvedilol average doses of 12.5 mg), and the mean heart rates of patients with HF are very high. Therefore, these patients should be considered for adding ivabradine besides beta blockers, if they are symptomatic and have a heart rate above 70 bpm with an ejection fraction (EF) <35%. Ivabradine should also be considered if beta blockers are contraindicated.

Anemia treatment: Iron deficiency (ferritin <100 ng/mL or 100–300 ng/mL if transferring saturation is <20%) may benefit from IV iron. The vials of common preparations come in 100 and 500 mg of iron as ferric carboxymaltose. The usual recommended total dose required in adults between 35 kg and 70 kg will be about 1500 mg of iron if the hemoglobin is <10 gm%.

A practical approach is to give a correction of 500–1000 mg of iron in patients who have a hemoglobin <10 with iron deficiency. This is diluted to 250 ml of saline and given over 30 min (modified for Indian patients based on the clinical experience). Hemoglobin is reassessed after about a month.

Blood pressure: It should be kept below 130/80 mmHg in high-risk categories such as diabetes and IHD.

Sleep apnea: It will benefit from continuous positive airway pressure.

Additional drugs: Metabolic modulation with drugs such as trimetazidine has been added in the previous guidelines for patients with HF and IHD and should be considered in patients with a combination of both. Thyroid status of the patient should be checked and corrected.

Device therapy

It has been covered in the previous guidelines and will be reviewed in detail in a subsequent issue.

Cardiac resynchronization therapy

CRT may be considered in symptomatic patients with an EF <35% and QRS width >130 ms.

Implantable cardioverter-defibrillator

ICD is advised for secondary prevention in patients with LV dysfunction who are survivors of sudden cardiac death or sustained ventricular tachycardia. For other indications such as Brugada Syndrome or hypertrophic cardiomyopathy, there are other guidelines.

It is not recommended for primary prevention in nonischemic LV dysfunction unless there are additional predictors such as nonsustained ventricular tachycardia or findings on EPS in light of the findings of the DANISH trial. In ischemic LV dysfunction with a low EF (<30%), they would still be beneficial in a selected subgroup.

Left ventricular assist devices in India

These are now available in India at multiple centers at costs ranging from 70 lakhs to 1 crore and are third- and fourth-generation devices. They are available as destination therapy and as bridge to transplant. Patients not suitable for heart transplant who have renal or liver disease or diabetes with multiple complications or old age or severe irreversible pulmonary hypertension can be considered for this device. Patients who have significant right ventricular dysfunction or bleeding problems cannot be considered for LVAD devices. In patients with right ventricular dysfunction, a biventricular ventricular assist device can be considered.

Heart transplant is now available in many centers. The cost varies from 2 lakhs in a government hospital to 20 lakhs or more in a private hospital for a transplant. Posttransplant medication cost about Rs 15–200,00 in the 1st year and then cost less. Patients with end-stage HF who are Class IV and have had two or more admissions for HF in the last 6 months should be considered for a heart transplant. They should be mentally fit, have a strong family and social support and sufficient financial support for the transplant and posttransplant care.

Role of Heart Failure Clinics

With all the available therapies available in India, medication adherence is a major problem, appropriate medications are given to only 25% of the patients, and mortality of admitted patients is as high as 30%. Therefore, we need to put the treatments together for each patient, and disease management programs,[25],[26] HF nurses, and HF clinics are useful in this direction. A small number of HF clinics have been started all over India in a number of government and private hospitals and they need to be increased.

The goals of heart failure program and clinic

Improvement in clinical outcomes

Improvement in patient well-being and quality of life

Identification of the contributors to HF progression

Management of the medical, socioeconomic, and psychological factors.

Patients who need to come to such a clinic

Patients recently hospitalized

High-risk patients, including those with

Renal insufficiency

Diabetes

Chronic obstructive pulmonary disease.

Persistent New York Heart Association (NYHA) Class III or IV symptoms

Persistent nonadherence to therapeutic regimens, or inadequate social or economic support.

Functional and quality of life assessment using NYHA Class, and 6 min walk test when appropriate. A quality of life assessment is useful and can be done using various tools like the Kansas City Cardiomyopathy Questionnaire

Medical therapy and drug evaluation: All patients should receive guideline-based therapy including ACEIs and beta blockers and other drugs as mandated and the doses adjusted to highest doses possible. Reasons for not achieving target doses should be documented. Self-use of diuretics should be taught. Patients should bring along their medicines and a list of their medicines on each visit. Indications of each medicine and their side effects should be explained to the patients by the second or third visit. Medication adherence should be evaluated

Device evaluation: Candidates for various devices such as CRT, ICD, or LVAD should be identified and given advice. Patients on these devices should be regularly monitored for change of HF status and device status. An electrophysiologist should also be following up these patients

Nutritional assessment: Nutrition advice on dietary sodium restriction, and fluid management has to be given

Follow-up: Follow-up should be planned carefully. After discharge, the first visit is planned within 7–10 days. High-risk patients can be contacted through telephone or a hospital visit within 72 h. Stable patients should be followed every 6–12 months. Electrolytes and renal function have to be checked for patients on diuretics

End-stage HF. In patients with end-stage HF, decisions for maximizing therapy, use of CRT, possible use of LVAD, or a heart transplant by referring to an appropriate center should be considered

Provider education: All personnels in the HF clinic should receive regular updates

Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, et al. 2016 ESC guidelines for the diagnosis and treatment of acute and chronic heart failure: The task force for the diagnosis and treatment of acute and chronic heart failure of the European society of cardiology (ESC) Developed with the special contribution of the heart failure association (HFA) of the ESC. Eur Heart J 2016;37:2129-200. [PUBMED]